Phase II Trial of RA-18C3 in Subjects With Moderate to Severe Acne Vulgaris

Inclusion criteria

• Age: ≥ 18
• Moderate to moderately severe inflammatory acne vulgaris:

• Investigator's Global Assessment grade of ≥ 3 and,
• ≥ 15 inflammatory lesions (no more than 6 nodules) and,
• ≥ 15 non-inflammatory lesions
• Four week washout period for topical and oral antibiotic treatment
• Four week washout period for topical retinoids
• Negative pregnancy test at screening and at specified time points throughout the trial. For subjects with reproductive potential, a willingness to utilize contraception during the study and including 3 months after study completion. Sexually active men must use an accepted method of contraception during the study and including 3 months after study completion.
• Subjects weighing ≥ 27 kg
• Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed

Exclusion criteria

• A diagnosis of Acne conglobata, acne fulminans, secondary acne, severe nodulocystic acne requiring treatment with isotretinoin, or other dermatologic conditions requiring interfering phototherapy, topical, or systemic treatment.
• Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
• Men with facial hair that would interfere with assessments
• History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months), ongoing congestive heart failure, and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
• Hemoglobin <10.0 g/dL, or WBC <3.0 x 103/mm3, or platelet count <125 x 103/mm3, or creatinine > 1.5mg/dL, or AST/ALT >2 x ULN, or alkaline phosphatase >2 x ULN
• Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody.
• History of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin.
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
• History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA)
• Infectious disease:

• CRP >30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening
• Immunodeficiency
• Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
• Receipt of a live (attenuated) vaccine within 1 month prior to Screening
• Major surgery within 28 days prior to Day 0
• Participation in an investigational drug or device trial within 30 days prior to Screening